A Phase 1, Double-blinded, Placebo-Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of HEV-239 (Hecolin(R)) Vaccine in Healthy US Adults
03/2024
Journal Article
Authors:
Kao, C. M.;
Rostad, C. A.;
Nolan, L. E.;
Peters, E.;
Kleinhenz, J.;
Sherman, J. D.;
Tippett, A.;
Shih, J. W. K.;
Yildirim, I.;
Agbakoba, V.;
Beresnev, T. ;
Ballou, C.;
Kamidani, S.;
Karmali, V.;
Natrajan, M.;
Scherer, E. M.;
Rouphael, N.;
Anderson, E. J.
Journal:
J Infect Dis
PMID:
38536442
URL:
https://www.ncbi.nlm.nih.gov/pubmed/38536442
Keywords:
Hepatitis E acute hepatitis immunization
Abstract:
INTRODUCTION: Establishing the safety and immunogenicity of a hepatitis E virus vaccine in multiple populations could facilitate broader access and prevent maternal and infant mortality. METHODS: We conducted a phase 1, randomized, double-blinded, placebo-controlled (4:1 vaccine: placebo) trial of 30 microg HEV-239 (Hecolin(R), Xiamen Innovax Biotech Company Limited, China) administered intramuscularly in healthy US adults aged 18-45 years. Participants were vaccinated on days 1, 29, and 180. Participants reported solicited local and systemic reactions for 7 days following vaccination and were followed through 12 months after enrollment for safety and immunogenicity (IgG, IgM). RESULTS: Solicited local and systemic reactions between treatment and placebo group were similar and overall mild. No participants experienced serious adverse events related to HEV-239. All participants receiving HEV-239 seroconverted at one month following the first dose and remained seropositive throughout the study. HEV-239 elicited a robust hepatitis E IgG response that peaked one month following the second dose (Geometric Mean Concentration (GMC) 6.16; 95% CI 4.40-8.63), was boosted with the third dose (GMC 11.50; 95% CI 7.90-16.75) and persisted through 6 months. CONCLUSIONS: HEV-239 is safe and elicits a durable immune response through at least 6 months after the third dose in healthy US adults. CLINICAL TRIALS REGISTRATION: NCT03827395. Safety Study of Hepatitis E Vaccine (HEV239) - Full Text View - ClinicalTrials.gov.
